By Counterforce Health Team in Brineura (cerliponase alfa) —

Get Brineura (Cerliponase Alfa) Covered by Aetna (CVS Health) in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Brineura Covered by Aetna in North Carolina

Fastest path to approval: Have a CLN2-specialized neurologist submit prior authorization through Aetna's provider portal with documented motor function scores ≥1 on the CLN2 Clinical Rating Scale, confirmed TPP1 deficiency, and an approved intraventricular administration site. Authorization typically takes 30-45 days (72 hours if expedited). If denied, North Carolina residents can appeal through Smart NC's external review program with binding decisions within 45 days (72 hours expedited). Start by contacting your neurologist to verify current authorization status and gather required documentation.

Table of Contents

Coverage Basics

Is Brineura Covered by Aetna?

Brineura (cerliponase alfa) requires prior authorization through Aetna/CVS Health for all covered plans. The medication is not automatically covered and must meet strict clinical criteria for CLN2 disease (neuronal ceroid lipofuscinosis type 2).

Which Plans Cover Brineura?

Coverage applies to:

  • Commercial Aetna plans through CVS Specialty Pharmacy
  • Medicaid managed care plans (where Aetna is the managed care organization)
  • Medicare Advantage plans with prescription drug coverage
Note: Self-funded employer plans may have different coverage rules. Contact your plan administrator to confirm coverage.

Prior Authorization Process

Who Submits the Prior Authorization?

The prior authorization must be submitted by a neurologist with CLN2 expertise or a physician in consultation with such a specialist, according to Aetna's clinical policy. Your treatment center's prior authorization specialist typically handles this submission.

Required Documentation Checklist

Before starting the authorization process, gather:

  • Insurance verification: Current Aetna member ID card and benefit verification
  • Clinical documentation: CLN2 diagnosis confirmation with TPP1 deficiency testing
  • Motor function assessment: Current CLN2 Clinical Rating Scale scores (motor domain ≥1 required)
  • Specialist consultation: Notes from CLN2-experienced neurologist
  • Administration site verification: Confirmation of approved intraventricular infusion facility
  • Prior therapy records: Documentation of any previous treatments (if applicable)

How to Check Authorization Status

Monitor your authorization through:

  • Aetna member portal at aetna.com
  • Calling Aetna member services at 1-800-872-3862
  • Contacting your neurologist's office for updates

Timing and Urgency

Standard Authorization Timeline

  • Initial review: 30-45 days from complete submission
  • Additional information requests: May extend timeline by 14-30 days
  • Approval notification: Sent to prescriber and patient within 2 business days

Expedited Reviews

For urgent situations (active neurological decline, upcoming surgery), request expedited review:

  • Timeline: 72 hours for decision
  • How to request: Call Aetna at 1-800-872-3862 and specify medical urgency
  • Required: Physician documentation of immediate medical necessity
Tip: Start authorization 60-90 days before treatment needs to begin, as specialized administration sites may require additional scheduling time.

Clinical Criteria

Eligibility Requirements

Aetna requires documentation of all the following:

Requirement Documentation Needed Source
Age ≥3 years Birth certificate or medical records FDA labeling
CLN2 diagnosis TPP1 enzyme deficiency testing Clinical lab results
Motor function CLN2 Clinical Rating Scale score ≥1 (motor domain) Aetna policy requirements
Specialist care Neurologist with CLN2 expertise Provider credentials verification
Administration site Approved intraventricular infusion facility Hospital/center verification

What Counts as Step Therapy?

Unlike many medications, Brineura typically doesn't require step therapy since it's the only FDA-approved disease-modifying treatment for CLN2. However, Aetna may require documentation that:

  • Supportive care measures are in place (seizure management, physical therapy)
  • The patient hasn't progressed beyond treatable disease stages

Costs and Financial Support

Understanding Your Out-of-Pocket Costs

Brineura's list price is approximately $27,000 per biweekly infusion ($702,000 annually), plus administration costs. Your actual cost depends on:

  • Formulary tier: Typically specialty tier (25-40% coinsurance)
  • Annual out-of-pocket maximum: Most plans cap annual costs at $3,000-$9,000
  • Deductible: May apply to first doses of the year

BioMarin Co-Pay Assistance Program

BioMarin offers financial support for commercially insured patients:

  • Covers: Co-pays, coinsurance, and deductibles
  • Eligibility: Commercial insurance required (not government plans)
  • Enrollment: Contact 1-866-906-6100 or complete online enrollment
  • No activation fee: Program is free to join
Important: Government insurance (Medicaid, Medicare) cannot use manufacturer co-pay assistance due to federal anti-kickback laws.

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Address Documentation Needed
"Not medically necessary" Submit clinical evidence of disease progression Updated CLN2 rating scales, neurologist notes
"Experimental/investigational" Provide FDA approval documentation FDA approval letter and labeling
"Non-formulary" Request formulary exception Medical necessity letter, lack of alternatives
"Administration site not approved" Verify intraventricular capability Hospital credentialing, neurosurgery department confirmation
"Age restriction" Document FDA-approved age range Birth certificate, FDA labeling for ≥3 years

Aetna Internal Appeals Process

Level 1 Appeal:

Level 2 Appeal:

  • When: After Level 1 denial
  • Decision time: Up to 45 days
  • Required: New clinical information or peer-to-peer review

North Carolina External Review Through Smart NC

If Aetna's internal appeals are denied, North Carolina residents can request external review through Smart NC:

Eligibility:

  • State-regulated plan (not self-funded employer plans)
  • Denial based on medical necessity
  • Internal appeals completed or expedited review qualified

Process:

  • Contact: 1-855-408-1212 (free advocacy support)
  • Timeline: 45 days for standard review, 72 hours for expedited
  • Decision: Binding on Aetna - if approved, coverage within 3 business days
  • Cost: Free to patients
From our advocates: We've seen families successfully overturn Brineura denials by emphasizing the medication's unique FDA approval for CLN2 and providing detailed motor function decline documentation. The key is showing that delaying treatment risks irreversible neurological damage that supportive care alone cannot prevent.

Renewal Requirements

When to Start Renewal Process

Begin Brineura renewal 60-90 days before authorization expires. Authorization periods are typically limited to 12 months maximum.

Required Renewal Documentation

Submit updated versions of:

  • Current CLN2 Clinical Rating Scale assessment: Must show continued motor function (score ≥1)
  • Neurologist consultation report: Documenting continued medical necessity
  • Treatment response documentation: Evidence of slowed disease progression
  • Safety monitoring results: Recent lab work and adverse event assessments
  • Administration site confirmation: Continued capability for intraventricular infusion

What Changes Trigger New Authorization?

  • Dose adjustments outside approved range
  • Change in administration frequency
  • Transfer to different infusion facility
  • Insurance plan changes

Specialty Pharmacy Requirements

Why Brineura Requires Specialty Pharmacy

Brineura must be dispensed through CVS Specialty Pharmacy due to:

  • Storage requirements: Refrigerated storage and handling
  • Administration complexity: Coordination with intraventricular infusion sites
  • Monitoring needs: Tracking of treatment response and adverse events
  • Cost management: Prior authorization and benefit verification

Working with CVS Specialty

Once approved, CVS Specialty will:

  • Contact you to coordinate delivery to your infusion site
  • Verify insurance benefits and co-pay assistance enrollment
  • Schedule deliveries to align with your infusion appointments
  • Provide 24/7 pharmacist support at 1-800-237-2767

Troubleshooting Common Issues

Portal or System Problems

If Aetna's portal is down:

  • Call provider services at 1-800-872-3862
  • Fax prior authorization to the number listed in current Aetna provider manual (verify current number)
  • Request confirmation of receipt

Missing Forms or Documentation:

  • Contact your neurologist's prior authorization team
  • Request copy of submitted documentation
  • Verify all required elements from checklist above

Authorization Delays

If authorization exceeds expected timeline:

  • Call Aetna to request status update
  • Ask for peer-to-peer review with medical director
  • Consider expedited review if clinically appropriate
  • Contact Smart NC for advocacy support at 1-855-408-1212

FAQ

Q: How long does Aetna prior authorization take for Brineura in North Carolina? A: Standard authorization takes 30-45 days from complete submission. Expedited reviews for urgent cases are completed within 72 hours. Start the process 60-90 days before treatment needs to begin.

Q: What if Brineura is non-formulary on my Aetna plan? A: Request a formulary exception by submitting a medical necessity letter documenting that Brineura is the only FDA-approved disease-modifying treatment for CLN2. Include evidence that supportive care alone is insufficient.

Q: Can I request an expedited appeal if my child's condition is worsening? A: Yes. Contact Aetna at 1-800-872-3862 to request expedited review. Provide physician documentation of immediate medical necessity and risk of irreversible harm from treatment delays.

Q: Does step therapy apply if my child tried treatments outside North Carolina? A: Document all prior treatments regardless of location. Since Brineura is the only disease-modifying therapy for CLN2, step therapy typically involves ensuring supportive care is optimized rather than trying alternative disease-modifying drugs.

Q: What happens if my Aetna appeal is denied? A: North Carolina residents can request external review through Smart NC within 120 days. This independent review is binding on Aetna and free to patients. Contact Smart NC at 1-855-408-1212 for assistance.

Q: How do I find a CLN2 specialist in North Carolina? A: The UNC Batten Disease Center of Excellence Affiliate provides specialized CLN2 care. Contact them for evaluation and treatment coordination.

Q: Can I use manufacturer co-pay assistance with Aetna? A: Yes, if you have commercial Aetna coverage. BioMarin's co-pay assistance program covers out-of-pocket costs for eligible patients. Contact 1-866-906-6100 to enroll.

Q: What if my child turns 18 during treatment? A: Brineura is approved for pediatric patients, but treatment typically continues into adulthood if showing benefit. Work with your neurologist to document ongoing medical necessity and consider transition to adult neurology care if needed.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients, clinicians, and specialty pharmacies. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that align with each insurer's specific requirements. For complex cases like Brineura, we help identify the exact denial basis and craft point-by-point rebuttals using FDA labeling, peer-reviewed studies, and recognized drug compendia to support medical necessity arguments.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with qualified healthcare professionals. Insurance coverage policies can change - always verify current requirements with your insurer and healthcare team. For additional help with insurance appeals in North Carolina, contact Smart NC at 1-855-408-1212.

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